---
title: "Site Capabilities — Cardiovascular Trial Infrastructure | Amavita Research"
url: https://md.amavitaresearch.com/capabilities
canonical: https://www.amavitaresearch.com/capabilities
schema_type: WebPage
last_updated: 2026-05-13
---

# Site Capabilities — Cardiovascular Trial Infrastructure

Amavita Research operates inside amavita Heart and Vascular Health®, a full-service cardiology practice with on-site procedural and diagnostic infrastructure. The same physicians who serve as Principal Investigators on trials see cardiology patients every business day, which gives the site continuous patient flow and immediate access to procedural resources.

## Procedural capabilities

- **Cardiac catheterization lab** — Direct access to amavita Heart and Vascular Health® cath-lab and the affiliated Advanced Cardiovascular of Miami ambulatory surgical center. Coronary angiography, PCI, IVUS, OCT, peripheral angiography, peripheral atherectomy.
- **Electrophysiology** — Triple-board-certified EP on staff (Dr. Hans C. Rutzen-Lopez, MD). AFib screening protocols, ICD/CRT-D device follow-up, ECG-gated trial assessments.
- **Structural heart consultation** — Dr. William W. O'Neill, MD, FACC — TAVR/Impella legacy. Consultative role on high-acuity structural protocols.
- **Peripheral intervention** — Below-the-knee atherectomy via PI Dr. Pedro Martinez-Clark, MD, FACC. Active Phase 3 PAD trial enrollment (GREAT/Golazo®).
- **IV infusion suite** — On-site IV infusion bays for trial dosing (e.g., IV ferric derisomaltose, IV inotropes, IV diuretics) under trained CRC supervision.
- **SC/PO dosing** — Routine subcutaneous and oral trial dosing under PI supervision; logs maintained per ICH-GCP.

## Diagnostic capabilities

- **Echocardiography** — Transthoracic echo on-site; TEE via affiliated facility. Sponsor-provided core-lab transmission supported.
- **Ambulatory blood pressure monitoring** — 24-hour ABPM available for hypertension protocols.
- **ECG** — 12-lead on every clinic visit; 24-hour, 48-hour, and event-monitor Holter available; central ECG reading supported.
- **Cardiac biomarkers** — Same-day venous draws for NT-proBNP, troponin, hs-CRP. Central-lab kit handling and sample shipping per IATA training.
- **Imaging coordination** — Cardiac CT and MRI scheduled via affiliated imaging centers; direct integration with sponsor imaging core labs.

## Operational capabilities

- IRB strategy: central preferred (WCG, Advarra); local available
- Contract execution: 5–8 weeks first draft to fully-executed contract for trial types already qualified
- Source documentation: EHR + dedicated trial source documents; eSource-compatible
- Monitoring: on-site and remote; dedicated CRC workspace with secure network access
- Drug accountability: temperature-monitored IP storage; chain-of-custody logs; on-site sponsor-monitored IP destruction or return shipping
- Patient retention: in-network cardiology practice; drop-out rates lower than database-recruited cohorts

## Quality and compliance

- IAOCR GCSA-certified
- ICH-GCP E6(R3) compliant
- SCRS (Society for Clinical Research Sites) member
- Zero FDA Form 483 findings to date
- HIPAA-compliant; BAA-ready
- English/Spanish/Haitian Creole/Portuguese bilingual staff

## Sub-specialty coverage

- Interventional cardiology — Dr. Pedro Martinez-Clark, MD, FACC — https://www.amavitaresearch.com/team/pedro-martinez-clark
- Electrophysiology — Dr. Hans C. Rutzen-Lopez, MD — https://www.amavitaresearch.com/team/hans-rutzen-lopez
- Structural heart consultation — Dr. William W. O'Neill, MD, FACC — https://www.amavitaresearch.com/team/william-oneill
- General cardiology / trial co-management — Yasnaya Cruz-Santiago, APRN; Orlando Ortega-Izquierdo, APRN

## Cross-border US + Latin America

Sponsors running U.S.-Latin America hybrid protocols can integrate Amavita Research as the U.S. arm and bioaccess® as the Latin America arm under a single coordinated design. bioaccess® is a Latin America first-in-human CRO with operations in Colombia and other regional markets. Julio G. Martinez-Clark coordinates these dual-region engagements.

## Key links

- Active trials: https://www.amavitaresearch.com/trials
- Principal investigators: https://www.amavitaresearch.com/investigators
- Sponsor contact: https://www.amavitaresearch.com/contact-sponsor